Medical balloon with reinforcing member

ABSTRACT

Catheter assemblies and methods for making and using catheter assemblies are disclosed. An example a catheter assembly includes a catheter shaft and a balloon attached to the catheter shaft. The balloon includes a body and a proximal waist portion. The proximal waist portion has a proximal end. The catheter assembly also has a fiber braid including one or more individual filaments disposed along the balloon. The fiber braid has a proximal end aligned with the proximal end of the waist portion. The catheter assembly also has a polymer sleeve disposed on the catheter shaft, wherein in the polymer sleeve abuts the proximal end of the balloon waist and the proximal end of the braid.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/789,324, filed Oct. 20, 2017, which claims the benefit of priorityunder 35 U.S.C. § 119 to U.S. Provisional Application Ser. No.62/414,325, filed Oct. 28, 2016, the entirety of which are incorporatedherein by reference.

TECHNICAL FIELD

The disclosure relates to intravascular medical devices such as medicalballoons and methods of making the same.

BACKGROUND

Medical balloons may be utilized in a variety of medical treatments. Forexample, is in an angioplasty procedure, a medical balloon may be usedto expand a diseased body lumen. Medical balloons may also be used todeliver and deploy an expandable endoprosthesis, such as a stent, at atarget site within a body lumen.

Medical balloons may be delivered to a target site by advancing aballoon catheter over a guidewire to the target site. In some cases, thepathway to a target site may be tortuous and/or narrow. Upon reachingthe site, the balloon may be expanded by injecting a fluid into theinterior of the balloon. Expanding the balloon may radially expand thestenosis such that normal blood flow may be restored through the bodylumen.

In some instances, a high pressure medical balloon may be utilized whentreating a particular target site (e.g., a stenosis). Further, in someinstances a balloon may be utilized which includes areinforcing/strengthening material. For example, to achieve the highpressure, some medical balloons may include one or more fiber braidsdesigned to increase the radial strength of the balloon. Examplesdisclosed herein may include medical devices and methods formanufacturing those devices having a fiber braid.

SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for medical devices. An example catheter assembly includesa catheter shaft and a balloon attached to the catheter shaft. Theballoon includes a body and a proximal waist portion, the proximal waistportion having an proximal end. The catheter assembly further includes afiber braid including one or more individual filaments disposed alongthe balloon. The fiber braid has a proximal end aligned with theproximal end of the waist portion. The catheter assembly furtherincludes a polymer sleeve disposed on the catheter shaft, wherein in thepolymer sleeve abuts the proximal end of the balloon waist and theproximal end of the braid.

Alternatively or additionally to any of the embodiments above, whereinthe polymer sleeve includes a distal end, and a portion of the distalend of the polymer sleeve extends into the proximal end of the waistportion.

Alternatively or additionally to any of the embodiments above, whereinthe polymer sleeve includes a distal end, and a portion of the distalend of the polymer sleeve extends into the proximal end of the braid.

Alternatively or additionally to any of the embodiments above, whereinone or more portions of the polymer sleeve is wicked along one or moreindividual filaments of the braid within the waist portion.

Alternatively or additionally to any of the embodiments above, whereinthe polymer sleeve is thermally bonded to the waist portion.

Alternatively or additionally to any of the embodiments above, whereinthe polymer sleeve is thermally bonded to the braid.

Alternatively or additionally to any of the embodiments above, whereinthe waist portion and the polymer sleeve are thermally bonded tocatheter shaft.

Alternatively or additionally to any of the embodiments above, whereinthe balloon waist comprises a polymer.

Alternatively or additionally to any of the embodiments above, whereinthe polymer of the balloon waist is different from the polymer thatcomprises the polymer sleeve.

Alternatively or additionally to any of the embodiments above, whereinthe polymer of the balloon waist has a melting point that is greaterthan the melting point of the polymer of the polymer sleeve.

Alternatively or additionally to any of the embodiments above, whereinthe melting point of the polymer of the balloon waist matches themelting point of the polymer of the polymer sleeve.

Alternatively or additionally to any of the embodiments above, whereinthe fiber braid comprises a material having a melting point greater thanthe melting point of the waist or the polymer of the polymer sleeve.

Alternatively or additionally to any of the embodiments above, whereinthe polymer sleeve is interlocked with one or more of the filaments ofthe fiber braid.

Another example catheter assembly includes:

a catheter shaft;

a balloon attached to the catheter shaft, the balloon including a bodyand a waist portion, the waist portion having an end;

a fiber braid including a plurality of individual filaments disposedalong the body and waist portion of the balloon, the individualfilaments having ends aligned with the end of the waist portion; and

a polymer sleeve disposed on the catheter shaft, the polymer sleeveabutting the end of the balloon waist, wherein one or more portions ofthe polymer sleeve extend along the individual filaments of the braid.

An example method of making a catheter assembly includes:

disposing a fiber braid about a balloon, the balloon comprising a waistportion and a body portion, the waist portion and the fiber braid eachhaving an end, wherein the end of the waist is aligned with the end ofthe braid;

disposing the balloon on a catheter shaft;

disposing a polymer sleeve on a catheter shaft abutting the end of thewaist portion;

applying heat to the at least a portion of the balloon waist and polymersleeve to thermally bond the polymer sleeve to the balloon waist,wherein a portion of the polymer sleeve extends into the waist portion.

Alternatively or additionally to any of the embodiments above, whereindisposing the polymer sleeve on the catheter shaft includes overlappingthe polymer sleeve with the end of the waist portion.

Alternatively or additionally to any of the embodiments above, whereinoverlapping the polymer sleeve with the end of the waist portionincludes position the polymer sleeve radially inward of the waistportion.

Alternatively or additionally to any of the embodiments above, wherein aportion of the polymer sleeve wicks along one or more fibers of thefiber braid.

Alternatively or additionally to any of the embodiments above, whereinthermally bonding the polymer sleeve to the balloon waist furtherincludes interlocking the polymer sleeve with one or more fibers of thefiber braid.

Alternatively or additionally to any of the embodiments above, whereinthe polymer sleeve extends into the waist portion such that the polymersleeve at least partially surrounds at least one or more fibers of thefiber braid.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The FIGS., and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIG. 1 illustrates an example medical device;

FIG. 2 illustrates a portion of the medical device of FIG. 1;

FIG. 3 illustrates a portion of the medical device of FIG. 1;

FIG. 4 illustrates an example manufacturing process for an examplemedical device;

FIG. 5 illustrates an example manufacturing process for an examplemedical device;

FIG. 6 illustrates an example manufacturing process for an examplemedical device;

FIG. 7 illustrates a cross-section of an example medical device.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the disclosureto the particular embodiments described. On the contrary, the intentionis to cover all modifications, equivalents, and alternatives fallingwithin the spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (e.g., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment described may include one or more particular features,structures, and/or characteristics. However, such recitations do notnecessarily mean that all embodiments include the particular features,structures, and/or characteristics. Additionally, when particularfeatures, structures, and/or characteristics are described in connectionwith one embodiment, it should be understood that such features,structures, and/or characteristics may also be used connection withother embodiments whether or not explicitly described unless clearlystated to the contrary.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of thedisclosure.

As used herein, the terms “proximal” and “distal” refer to that which isclosest to the user such as a surgeon and that which is furthest fromthe user respectively.

As discussed above, medical balloons may be utilized in a variety ofmedical treatments. For example, in an angioplasty procedure, a medicalballoon may be used to widen a diseased body lumen, such as a arteriesin the vasculature. A medical balloon may also be used to deliver anddeploy an expandable endoprosthesis, such as a stent, at a target sitewithin a body lumen.

Medical balloons may be utilized in a variety of medical treatments. Forexample, in an angioplasty procedure, a medical balloon may be used toexpand a diseased body lumen. Medical balloons may also be used todeliver and deploy an expandable endoprosthesis, such as a stent, at atarget site within a body lumen.

Medical balloons may be delivered to a target site by advancing aballoon catheter over a guidewire to the target site. In some cases, thepathway to a target site may be tortuous and/or narrow. Upon reachingthe site, the balloon may be expanded by injecting a fluid into theinterior of the balloon. Expanding the balloon may radially expand thestenosis such that normal blood flow may be restored through the bodylumen.

In some instances it may be desirable to utilize high pressure medicalballoons when treating a particular target site (e.g., a stenosis).Further, in some instances it may be desirable to utilize a balloonwhich includes a reinforcing/strengthening material. For example, toachieve the high pressure, some medical balloons may include one or morefiber braids designed to increase the radial strength of the balloon.Examples disclosed herein may include medical devices and methods formanufacturing those devices having a fiber braid.

FIG. 1 shows example balloon catheter system 11. System 11 may includean expandable medical balloon 10 mounted to a distal end of a cathetershaft 30. The catheter shaft 30 may extend from a manifold assembly 40positioned at a proximal end of the catheter shaft 30. Balloon 10 isshown having a body portion 12, a proximal cone portion 14, a distalcone portion 16, a proximal waist portion 15, and a distal waist portion17. Balloon 10 may be secured to the catheter shaft 30 at the proximalwaist 15 and distal waist portions 17, respectively.

Catheter shaft 30 may include a guidewire lumen (not shown) extendingtherein and an inflation lumen (not shown) extending therein forinflation of balloon 10. Alternatively, the catheter shaft 30 mayinclude an inner tubular member defining a guidewire lumen and an outertubular member disposed around the inner tubular member, whereby aninflation lumen may be defined between the inner tubular member and theouter tubular member.

Additionally, and as illustrated in FIG. 1, balloon 10 may include afiber braid 18 disposed thereon. Fiber braid 18 may be disposed along anouter surface of balloon 10. However, this is not intended to belimiting. Rather, it is contemplated that braid 18 may be partially orfully embedded in the wall of balloon 10. It can further be appreciatedthat fiber braid 18 may extend around the circumference of balloon 10.Specifically, braid 18 may wrap around the circumference of balloon 10.

Fiber braid 18 may include one or more filaments 20. Further, fiberbraid 18 may be configured such that the one or more filaments 20 arebraided, wound, wrapped, woven, etc. around the outer surface and/orpartially or fully within the wall of balloon 10. Additionally,filaments 20 may be braided, wound, wrapped, woven, etc. in a variety ofconfigurations around the outer surface and/or partially or fully withinthe wall of balloon 10.

In some examples, the inner surface of at least one of the proximalwaist portion 15 and/or the distal waist portion 17 are bonded (e.g.,thermally, adhesively, etc.) to an outer surface of a portion of thecatheter shaft 30 prior to bonding of the fiber braid 18 to the proximalwaist portion 15 and/or the distal waist portions 17. As used herein,thermal bonding refers to the melting of materials or a portion thereofby applying heat, laser, welding or some combination thereof, to obtaina mixing or bonding of the materials at the material interface.Alternatively, an inner surface of the fiber braid 18 may be adhesivelybonded to an outer surface of the proximal waist portion 15 and distalwaist portion 17. Additionally, it is contemplated the fiber braid 18may be attached to balloon 10 via any suitable process, including heatwelding, laser welding, etc.

Further, a suitable adhesive may be employed for bonding the fiber braid18 to the balloon 10, including proximal waist portion 15, and distalwaist portion 17. The adhesive may include, but is not limited to, forexample, thermoset adhesives that suitably cure either via a chemicalreaction or irradiation. Specific examples of suitable thermosetadhesives include moisture cure and radiation cure such as ultraviolet(UV) radiation cure, e-beam, and the like. In some embodiments, theadhesive is a thermoset cyanoacrylate adhesive. A particular example isLoctite 4011 available from Henkel Adhesives.

FIG. 2 illustrates the proximal portion of an example balloon 10 bondedto a portion of catheter shaft 30. As shown in FIG. 2, one of morefilaments 20 of fiber braid 18 may extend in a proximal direction fromthe balloon body 12, along the proximal balloon cone 14 and furtheralong the proximal balloon waist 15. Additionally, FIG. 2 illustrates abonding sleeve 22 disposed along the proximal portion of the proximalwaist 15. As will be described in detail below, bonding sleeve 22 may bedesigned to cover, encapsulate, embed and/or seal the proximal portionof the braid 18 located at the proximal portion of the proximal waist15.

The detailed view shown in FIG. 2 illustrates that a portion of bondingsleeve 22 may extend along a proximal portion of the proximal waist 15.As will be described in greater detail below, the bonding sleeve 22 maybe designed such that it extends in a proximal-to-distal direction alongat least a portion the proximal waist 15. Specifically, the is detailedview of FIG. 2 shows that bonding sleeve 22 may extend over the end ofthe proximal waist 15 of balloon 10 (the end of the proximal waist 15 ofballoon 10 is depicted as dashed line 25 in the detailed view of FIG.2). Additionally, the detailed view of FIG. 2 illustrates that bondingsleeve 22 may wick and/or flow in a distal-to-proximal direction alongthe fibers 20 of braid 18. A distal portion 24 of bonding sleeve 22 isdepicted in both the detailed and non-detailed views of FIG. 2. It canbe appreciated the distal portion 24 of bonding sleeve 22 may or may notterminate a uniform distance from end of proximal waist 15. For example,it can be appreciated that as bonding sleeve 22 wicks and/or flows in adistal-to-proximal direction along the fibers 20 of braid 18, that someportions of bonding sleeve may advance further along the braid 18 thanother adjacent portions (as depicted by the jagged line of distalportion 24 of bonding sleeve 22).

FIG. 3 illustrates an example step in manufacturing catheter system 11.FIG. 3 shows that the proximal waist 15 may be trimmed to an appropriatelength prior to bonding the proximal waist 15 of balloon 10 to cathetershaft 30. FIG. 3 illustrates that the proximal waist 15 of balloon 10has been cleanly cut along proximal edge 28. Further, FIG. 3 illustratesthat the trimming process of proximal balloon waist 15 may reveal aproximal face 29 of the proximal waist 15. Further, the proximal face 29shows the ends 27 of one or more fibers 20 of braid 18. The ends 27 offibers are positioned along the proximal face 29. In other words, thetrimming process may result in the end 28 of the proximal balloon waistaligning with the ends 27 of the one or more fibers 20 of braid 18.

As shown in FIG. 3, it can be appreciated the trimming process mayresult in one or more of fibers 20 becoming exposed along either theproximal face 29 and/or along the outer surface of proximal balloonwaist 15. Further, the trimming process may cause the ends 27 of the oneor more fibers 20 to become unraveled, frayed, exposed, released and/orunattached to the proximal waist 15 and/or proximal face 29. In someinstances, the ends 27 of one or more fibers 20 may extend radiallyoutward of the outer diameter of the proximal waist 15. Further, it canbe appreciated that it may be undesirable to have the ends 27 of one ormore fibers 20 extending/projecting away from balloon waist 15 as theymay interfere with a medical devices and/or delivery systems utilized inconjunction with catheter system 11. For example, the ends 27 of the oneor more fibers 20 may interfere with a stent being positioned on balloon10. Therefore, it may be desirable to recapture, cover, encase,encapsulate, overlay and/or seal the ends 27 of the one or more fibers20 within another material. For example, it may be desirable torecapture, cover, encase, encapsulate, overlay and/or seal the ends 27of the one or more fibers 20 with a bonding sleeve 22 as describedabove.

FIG. 4 shows an example assembly step in manufacturing catheter system11. FIG. 4 shows a bonding sleeve 22 (prior to being melted) beingpositioned on catheter shaft 30. Further, FIG. 4 shows catheter shaft 30extending through the proximal waist 15. Additionally, FIG. 4 showsballoon 10 (including proximal waist 15) being advanced toward bondingsleeve 22. However, while FIG. 4 illustrates balloon 10 (includingproximal waist 15) being advanced toward bonding sleeve 22, it is alsocontemplated that bonding sleeve 22 may be advanced toward proximalwaist 15.

FIG. 5 shows another example assembly step in manufacturing cathetersystem 11. FIG. 5 shows that bonding sleeve 22 and/or and proximal waist22 have been moved to a position in which it abuts proximal waist 15 ofballoon 10. In other words, FIG. 5 illustrates that a portion of theproximal face 29 (shown in FIG. 3) of proximal waist 15 may create abutt joint (e.g., a joint in which the proximal face of the proximalwaist 15 may contact a distal face of the bonding sleeve 22) prior tothe bonding process. However, this is not intended to be limiting. Otherarrangements of proximal waist 15, bonding sleeve 22 and catheter shaft30 are contemplated. For example, it is contemplated that the distalportion of bonding sleeve 22 may overlap with the proximal end of theproximal waist 15 prior to the bonding process.

FIG. 6 shows another example assembly step in manufacturing cathetersystem 11. FIG. 6 shows an example process for melting bonding sleeve 22such that it melts and/or reflows over the proximal end of the proximalwaist 15. FIG. 6 illustrates a piece of heat shrink 36 positioned overthe proximal waist 15, the bonding sleeve 22 and the catheter shaft 30.Additionally, FIG. 6 shows energy 38 (e.g., laser energy, thermalenergy, etc.) being applied to the heat shrink 36. Further, the heatshrink 36 may transfer/disperse the energy to the bonding sleeve 22,proximal waist 15 and/or the catheter shaft 30, thereby thermallybonding the bonding sleeve 22 to the proximal waist 15 and/or thecatheter shaft 30.

It can be appreciated that the melting points of the balloon material,fibers 20, is bonding sleeve 22, and catheter shaft may be the same orthey may be different. For example, it may be desirable for the bondingsleeve 22 to be made from a material having a melting point which islower than the balloon material, fibers 20 and/or bonding sleeve 22. Forexample, all or a portion of balloon 10 (including proximal balloonwaist 15) may be manufactured from Pebax®, which has an approximate melttemperature of 220° C. All or a portion of catheter shaft 30 may bemanufactured from Grilamid L20®, for example, which has an approximatemelt temperature of 178° C. All or a portion of fibers 20 may includeVectran®, for example, which has an approximate melt temp of 330° C. anddoes not melt at bonding temps.

It can be appreciated that the catheter system 11 illustrated anddescribed with respect to FIG. 2 may be the configuration of thecatheter system 11 after processing the catheter system as described inFIG. 6. In other words, the illustration and description of the bondingsleeve and proximal waist interface in FIG. 2 may represent the catheterafter it undergoes the processing and bonding steps as described inFIGS. 3-6.

FIG. 7 illustrates a cross-sectional view of the proximal waist 15,bonding sleeve 22 and catheter shaft 30 after the bonding step has beenperformed as described in FIG. 6. FIG. 7 illustrates one or more ends 27of fibers 20 being captured, covered, encased, encapsulated, overlaidand/or sealed by the material of bonding sleeve 22. For example, FIG. 7shows that after energy 38 is applied during the assembly step asdescribed in FIG. 6, the bonding sleeve 22 may melt and/or reflow intoand around the ends 27 of fibers 20 of braid 18. It is noted that FIG. 7does not show heat shrink 36 (shown in FIG. 6) positioned over theproximal waist 15 and/or bonding sleeve 22 because heat shrink 36 isremoved from the proximal waist 15 and bonding sleeve 22 once sufficientenergy has been applied to reflow the proximal waist 15 and bondingsleeve 22 into the cross-section view shown in FIG. 7. In other words,bonding sleeve 22 may melt and/or reflow into the proximal waist 15which includes fibers 20 of fiber braid 18. It can be furtherappreciated the trimming of balloon 10 as described in FIG. 3 mayresults in cavities, channels, openings and/or spaces existing betweenfibers 20. Therefore, the cavities, channels, openings and/or spaces maypermit the bonding sleeve 22 material to wick up one or more fibers 20of braid 18, thereby surrounding, covering, encasing, encapsulating,overlaid and/or sealing the fibers 20 within the bonding material 22.

Balloon 10 may be pre-formed by radial expansion of a tubular parison,which is optionally also longitudinally stretched. The extruded parisonmay be radially expanded in a mold or by free-blowing. Alternatively,the parison may be pre-stretched longitudinally before expansion orreformed in various ways to reduce thickness of the balloon cone andwaist regions prior to radial expansion. The blowing process may utilizepressurization under tension, followed by rapid dipping into a heatedfluid; a sequential dipping with differing pressurization; a pulsedpressurization with compressible or incompressible fluid, after thematerial has been heated. Heating may also be accomplished by heatingthe pressurization fluid injected into the parison.

Balloon 10 may be formed from balloon materials including compliant,semi-compliant, and non-compliant materials. These materials may includethermoplastic polymers, elastomers, and non-elastomers. Such materialsmay include low, linear low, medium, and high density polyethylenes,polypropylenes, and copolymers and terpolymers thereof polyurethanes;polyesters and copolyesters; polycarbonates; polyamides; thermoplasticpolyimides; polyetherimides; polyetheretherketones (PEEK) and PES(polyether sulfone); and copolymers and terpolymers thereof. Physicalblends and copolymers of such materials may also be used. Examples ofpolyesters include, but are not limited to, polyethylene terephthalate(PET), polyethylene naphthalate (PEN), polybutylene terephthalate, andcopolymers thereof. Examples of polyamides which may be used includenylon 6, nylon 64, nylon 66, nylon 610, nylon 610, nylon 612, nylon 46,nylon 9, nylon 10, nylon 11, nylon 12, and mixtures thereof. Examples ofsuitable polyurethanes include, but are not limited to, aromaticpolyether-based thermoplastic polyurethanes (TPUs) such as thoseavailable under the tradename of Tecothane® from Thermedics;thermoplastic polyurethane elastomer available under the tradename ofPellethane®, such as Pellethane® 2363-75D from Dow Chemical Co.; andhigh strength engineering thermoplastic polyurethane available under thetradename of Isoplast®, such as Isoplast® 301 and 302 available from DowChemical Co.

In some embodiments, the balloon 10 may be formed from poly(ether-block-amide) copolymers. The polyamide/polyether block copolymersare commonly identified by the acronym PEBA (polyether block amide). Thepolyamide and polyether segments of these block copolymers may be linkedthrough amide linkages, or ester linked segmented is polymers (e.g.,polyamide/polyether polyesters). Such polyamide/polyether/polyesterblock copolymers are made by a molten state polycondensation reaction ofa dicarboxylic polyamide and a polyether diol. The result is a shortchain polyester made up of blocks of polyamide and polyether. Polymersof this type are commercially available under the tradename of Pebax®from Arkema. Specific example are the “33” series polymers with hardness60 and above, Shore D scale, for example, Pebax® 6333, 7033, and 7233.These polymers are made up of nylon 12 segments and poly(tetramethyleneether) segments linked by ester groups.

Polyester/polyether segmented block copolymers may also be employedherein. Such polymers are made up of at least two polyester and at leasttwo polyether segments. The polyether segments are the same aspreviously described for the polyamide/polyether block copolymers usefulin the disclosure. The polyester segments are polyesters of an aromaticdicarboxylic acid and a two to four carbon diol.

In some embodiments, the polyether segments of the polyester/polyethersegmented block copolymers are aliphatic polyethers having at least 2and no more than 10 linear saturated aliphatic carbon atoms betweenether linkages. Ether segments may have 4-6 carbons between etherlinkages, and can be poly(tetramethylene ether) segments. Examples ofother polyethers which may be employed in place of or in addition totetramethylene ether segments include polyethylene glycol, polypropyleneglycol, poly(pentamethylene ether) and poly(hexamethylene ether). Thehydrocarbon portions of the polyether may be optionally branched. Anexample is the polyether of 2-ethylhexane diol. Generally such brancheswill contain no more than two carbon atoms. The molecular weight of thepolyether segments is suitably between about 400 and 2,500, such asbetween 650 and 1000.

In some embodiments, the polyester segments of the polyester/polyethersegmented block copolymers are polyesters of an aromatic dicarboxylicacid and a two to four carbon to diol. Suitable dicarboxylic acids usedto prepare the polyester segments of the polyester/polyether blockcopolymers are ortho-, meta-, or para-phthalic acid,napthalenedicarboxylic acid, or meta-terphenyl-4,4′-dicarboxylic acids.Specific examples of polyester/polyether block copolymers arepoly(butylene terephthalate)-block-poly (tetramethylene oxide) polymerssuch as Arnitel® EM 740, sold by DSM Engineering Plastics, and Hytrel®polymers, sold by DuPont, such as Hytrel® 8230.

The above lists are intended for illustrative purposes only, and not asa limitation on the present disclosure. It is within purview of those ofordinary skill in the art to select other polymers without departingfrom the scope of this disclosure.

Balloon 10 may be capable of being inflated to relative high pressures.For example, the balloon 10 may be inflated to pressures up to about 20atm or more, or up to about 25 atm or more, or up to about 30 atm ormore, or up to about 40 atm or more, or up to about 45 atm or more, orup to about 50 atm or more, or about 20-50 atm, or about 25-40 atm, orabout 30-50 atm. At such elevated pressures, the bond between theproximal waist portion 15 and the catheter shaft 30 (as well as the bondbetween the distal waist portion 17 and the catheter shaft 30) ismaintained. Furthermore, the fluid tight bond between the fiber braid 18and the balloon 10 is also maintained at these elevated pressures.

In some embodiments, the balloon 10 is formed from a compliant material.In some embodiments, the balloon 10 is formed from an elastomer, such asa block copolymer elastomer. The block copolymer elastomer may be apoly(ether-block-amide) copolymer. The balloon can also be formed oflayers, for example, an inner layer formed of a first polymer materialand an outer layer formed from a second polymer material different thanthe first polymer material. For example, in some embodiments, the innerlayer may be formed from an elastomeric polymer material, for example, ablock copolymer elastomer, and the outer layer is formed from anon-elastomeric polymer material. In some embodiments, the inner layeris formed of a poly(ether-block-amide) copolymer; and the outer layer isformed of a polyamide.

The fiber braid 18 may be formed from a suitable polymer material.General classes of suitable fiber braid materials include, for example,polyesters, polyolefins, polyamides, polyurethanes, liquid crystalpolymers, polyimides, and mixtures thereof. More specific examplesinclude, but are not limited to, polyesters such as polyethyleneterephthalate (PET), polybutylene terephthalate (PBT), andpolytrimethylene terephthalate (PTT). Polyamides include nylons andaramids such as Kevlar®. Liquid crystal polymers include Vectran®.Polyolefins include ultrahigh molecular weight polyethylene, such asDyneema® sold by DSM Dyneema BVm Heerlen, Netherlands, Spectra® fibers,sold by Honeywell, and very high density polyethylene, and polypropylenefibers. Elastomeric fibers can be used in some cases.

In some embodiments, the fiber braid 18 comprises an ultra highmolecular weight polyethylene (UHMPE). Commercially available UHMPEsinclude, but are not limited to, Dyneema® fiber available from DSMDyneema BVm Heerlen, Netherlands, Spectra® fiber available fromHoneywell in Morristown and Pegasus UHMWPE fiber available from PegasusMaterials in Shanghai, China. The UHMWPE fibers provide excellentstrength and modulus with a small filament size to provide excellentballoon coverage and maintaining a minimal profile. However, whenmelted, the fibers lose their high molecular orientation andconsequently, may also lose their bond tensile strength at the proximalwaist portion 15 and/or the distal waist portion 17 of the balloon 10 ata thermal bond interface.

Additionally coatings may be optionally applied to the balloon 10, suchas between the outer surface of the balloon 10 and the fiber braid 18,over the outer surface of the fiber braid 18 or both. In someembodiments, the coating includes a thermoplastic elastomer. In otherinstances, the coating includes a thermoplastic polyurethane. In someinstances, the coating of a thermoplastic polyurethane may be applied tothe balloon 10 using a suitable technique (e.g., dip coating, spraycoating, rolling, or the like) prior to braiding and is also applied tothe balloon/braid after braiding.

The catheter shaft 30 and/or other parts of catheter system 11 (e.g.,bonding sleeve 22) may be formed from any suitable shaft material.Examples include, but are not limited to, polytetrafluoroethylene(PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylenepropylene (FEP), polyoxymethylene (POM, for example, DELRIN® availablefrom DuPont), polyether block ester, polyurethane (for example,Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC),polyether-ester (for example, ARNITEL® available from DSM EngineeringPlastics), ether or ester based copolymers (for example,butylene/poly(alkylene ether) phthalate and/or other polyesterelastomers such as HYTREL® available from DuPont), polyamide (forexample, DURETHAN® available from Bayer or CRISTAMID® available from ElfAtochem), elastomeric polyamides, block polyamide/ethers, polyetherblock amide (PEBA, for example available under the trade name PEBAX®),ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE),Marlex high-density polyethylene, Marlex low-density polyethylene,linear low density polyethylene (for example REXELL®), polyester,polybutylene terephthalate (PBT), is polyethylene terephthalate (PET),polytrimethylene terephthalate, polyethylene naphthalate (PEN),polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI),polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (for example, KEVLAR®), polysulfone,nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon),perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin,polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the shaft materialmixture can contain up to about 6 percent LCP. In some embodiments, thecatheter shaft 30 is formed from a polyamide, for example Grilamid®which is commercially available from EMS-Grivory.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The disclosure's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A method of making a catheter assembly, themethod comprising: disposing a fiber braid about a balloon, the ballooncomprising a waist portion and a body portion, the waist portion and thefiber braid each having an end, wherein the end of the waist portion isaligned with the end of the fiber braid; disposing the balloon on acatheter shaft; disposing a polymer sleeve on the catheter shaftadjacent the end of the waist portion; and applying heat to the waistportion and polymer sleeve to thermally bond the polymer sleeve to thewaist portion, wherein a portion of the polymer sleeve extends into thewaist portion and an outer diameter of the catheter assembly remainssubstantially constant along the waist portion of the balloon and anentirety of the polymer sleeve.
 2. The method of claim 1, whereindisposing the polymer sleeve on the catheter shaft includes abutting thepolymer sleeve with the end of the waist portion.
 3. The method of claim1, wherein disposing the polymer sleeve on the catheter shaft includesoverlapping the polymer sleeve with the end of the waist portion.
 4. Themethod of claim 3, wherein overlapping the polymer sleeve with the endof the waist portion includes positioning the polymer sleeve radiallyinward of the waist portion.
 5. The method of claim 1, wherein a portionof the polymer sleeve wicks along one or more fibers of the fiber braid.6. The method of claim 1, wherein thermally bonding the polymer sleeveto the waist portion further includes interlocking the polymer sleevewith one or more fibers of the fiber braid.
 7. The method of claim 1,wherein the polymer sleeve extends into the waist portion such that thepolymer sleeve at least partially surrounds at least one or more fibersof the fiber braid.
 8. The method of claim 1, wherein thermally bondingthe polymer sleeve to the waist portion includes thermally bonding thepolymer sleeve to the catheter shaft.
 9. The method of claim 1, whereinthe waist portion includes a polymer.
 10. The method of claim 9, whereinthe polymer of the waist portion is different from a polymer of thepolymer sleeve.
 11. The method of claim 9, wherein the polymer of thewaist portion has a melting point that is greater than a melting pointof a polymer of the polymer sleeve.
 12. The method of claim 9, whereinthe polymer of the waist portion has a melting point that matches amelting point of a polymer of the polymer sleeve.
 13. The method ofclaim 9, wherein the fiber braid comprises a material having a meltingpoint greater than a melting point of the waist portion or a polymer ofthe polymer sleeve.
 14. A method of making a catheter assembly, themethod comprising: disposing a fiber braid about a balloon, the ballooncomprising a proximal waist portion and a body portion, the proximalwaist portion and the fiber braid each having a proximal end; cuttingthe proximal waist portion and fiber braid to expose a proximal face,wherein the proximal face exposes ends of one or more fibers of thefiber braid; disposing the balloon on a catheter shaft; disposing apolymer sleeve on the catheter shaft adjacent the proximal end of theproximal waist portion; and applying heat to the proximal waist portionand polymer sleeve to thermally bond the polymer sleeve to the proximalwaist portion, wherein an outer diameter of the catheter assemblyremains substantially constant along the proximal waist portion of theballoon and an entirety of the polymer sleeve.
 15. The method of claim14, wherein a portion of the polymer sleeve extends into the proximalwaist portion such that the polymer sleeve at least partially surroundsat least one or more fibers of the fiber braid.
 16. The method of claim14, wherein a portion of the polymer sleeve wicks along one or morefibers of the fiber braid and interlocks the polymer sleeve with the oneor more fibers of the fiber braid.
 17. The method of claim 14, whereinthe proximal waist portion includes a polymer that is different from apolymer of the polymer sleeve.
 18. The method of claim 14, wherein theproximal waist portion includes a polymer having a melting point that isgreater than a melting point of a polymer of the polymer sleeve.
 19. Themethod of claim 14, wherein the proximal waist portion includes apolymer having a melting point that matches a melting point of a polymerof the polymer sleeve.
 20. The method of claim 14, wherein the proximalwaist portion includes a polymer, and the fiber braid comprises amaterial having a melting point greater than a melting point of thepolymer of the proximal waist portion or a polymer of the polymersleeve.